Table 3.

Initial Visit:

History and Physical

·        History of CHF?

·        History of malignancy or serious infections (hepatitis, TB, HIV, other)?

·        History or family history of multiple sclerosis?

·        History of other neurological disease including seizure disorders?

·        History of COPD and smoking?

·        Total body skin exam for skin cancer

·        Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        History of diabetes?

·        Have you lived in Southwest (risk of coccidiomycosis) or Southeast – Ohio and Mississippi River Valleys (risk of histoplasmosis or blastomycosis)?

·        Travel to area endemic for TB?

·        Live vaccine within past month – you or household member?

·        Medications: Anakinra; cyclosporine; abatacept; natalizumab; other anti-TNF agents; rituximab; methotrexate; corticosteroids; cyclophosphamide (increased risk of solid malignancies in Wegener’s granulomatosis); warfarin (levels can be decreased by anti-TNF agents)

·        Wegener’s granulomatosis? (increased risk of malignancy with Remicade)

·        Major surgery in next month?

·        Active infection? Hold dose for infection or sepsis

·        For Enbrel - History of alcoholism? (increased mortality in alcoholic hepatitis)

Labs

·        CBC, CMP

·        TB test (for PPD, consider >5mm as positive)

·        Hepatitis B screen: Hepatitis B sAg, Hepatitis B sAb, Hepatitis B cAb

·        Influenza vaccine (if flu season)

·        Baseline ANA (optional)

·        HIV (optional) – especially with erythrodermic psoriasis

·        Cardiovascular risk panel: CRP, homocysteine, HbA1C, lipid profile (if screening for psoriasis) (optional)

·        Pneumovax (optional)

Administration Considerations

·        Pre-medicate with acetaminophen and antihistamines

·        Have acetaminophen, antihistamines, corticosteroids, and/or epinephrine available for immediate use

 

Counseling/Other

·        Infusion reaction – ANAPHYLAXIS (e.g., angioedema; bronchospasm; hypotension), serum sickness-like reaction (polyarthralgias, myalgia, fever, rash, headache, sore throat, dysphagia, hand and facial edema), seizure

·        Risk of anaphylaxis if previously had Remicade more than 6 months prior

·        Can worsen existing malignancies

·        Malignancy:

o    Non-Hodgkin's lymphoma and Hodgkin's disease; breast, colorectal, melanoma, acute and chronic leukemia

o    Lymphoma and other malignancies in children and adolescents

o    Non-melanoma skin cancer with prior phototherapy

o    If h/o COPD and smoking, risk of lung or head and neck malignancy

o    Hepatosplenic T-cell lymphoma - all in Crohn's or ulcerative colitis, mostly adolescent or young adult males AND azathioprine or 6-mercaptopurine at or prior to diagnosis (although rheumatologists frequently use this combination)

·        Risk of reactivation of latent TB

o    Risk is higher with TNF-blocking monoclonal antibodies than with Enbrel

·        Serious, sometimes fatal, infection (especially with methotrexate or corticosteroids): bacterial (including sepsis), mycobacterial, invasive fungal, viral, and opportunistic infections, such as tuberculosis (including reactivation), histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, listeriosis

·        Exacerbation or new onset of demyelinating disease, e.g., multiple sclerosis, seizure disorder

o    Rare cases of optic neuritis, seizure, CNS manifestations of systemic vasculitis, peripheral demyelinating disorders such as Guillain-Barre syndrome; Caution with pre-existing demyelinating or seizure disorders

·        Can worsen moderate to severe heart failure or cause new-onset heart failure

·        May lower incidence of coronary artery disease (a benefit)

·        Loss of efficacy can occur with time, which is sometimes prevented with coadministration of low-dose methotrexate¹⁴.

·        Works fast (PASI 50 at week 2)¹⁴ (a benefit)

·        Lupus-like syndrome

·        Reactivation of hepatitis B

·        Hepatotoxicity - acute liver failure, jaundice, hepatitis, cholestasis, autoimmune hepatitis

·        Incidence of elevated liver enzymes and liver complications is somewhat higher with Remicade than with other TNF-alpha inhibitors⁴.

·        Cytopenias: pancytopenia, aplastic anemia, leucopenia, thrombocytopenia

·        Avoid live vaccines – self and household members

·        Pediatric Patients: Up to date on vaccines before starting?

·        Formation of anti-Remicaide antibodies after drug-free intervals of >16 weeks, lower incidence in those taking methotrexate concomitantly, associated with decreased efficacy

·        If you have diabetes, there is higher chance for infection.

·        For Enbrel - If you have diabetes, there is a risk for hypoglycemia and a higher chance for infection when serum glucose is poorly controlled

·        For Simponi and Remicade - New-onset or worsening psoriasis

·        For Cimzia - Erroneously elevated aPPT tests

·        For Cimzia - Intestinal obstruction (with Crohn's patients)

 

Follow-up Visit:

History and Physical

·        Every six months: Total body skin exam for skin cancer

·        Every six months: Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        Any new infection – hold dose for active infection or sepsis

·        When was last dose (< 6 months?) – risk for anaphylaxis if > 6 months?

·        Is there sustained clinical efficacy in the treatment interval? Skin? Joints?

·        Any signs of heart failure

·        Major surgery in next month?

·        Other interval history

Labs

·        Every visit for first 4 infusions, then approximately every three months: CBC, CMP

·        Every year: TB test (consider induration of >5mm as positive)

·        Influenza vaccine annually (in flu season)

·        Pre-medicate with acetaminophen and antihistamines

·        In HBV carriers, check liver panel for laboratory signs of hepatitis B reactivation

·        ANA and anti-ds-DNA (if lupus-like symptoms)

 

Other

·        Any live vaccines in past month?

·        Any household members getting live vaccine?